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ISO 11607 packaging validation

We do the packaging validation for your 510(k).

The submission is in front of you, and the packaging still has to be validated to ISO 11607. It is a discipline of its own, and it lands on you whether this is your first submission or your fifteenth. We take it off your desk and give it back finished: the study, the data, and the reasoning that ties every number to the clause it answers, built to be defended when a reviewer pushes on it. You look it over, and there is nothing left for you to build.

Book a 30-minute callGap assessment: $2,500 fixed

No thumb on the scale

Where your device needs a test, we place it with the accredited laboratory that fits the method and the schedule. No laboratory or supplier pays us a commission, a rebate or a referral fee, and their charge reaches your invoice at cost, on its own line. So the testing we place is only ever the testing your file needs.

In short

What we do

Probity Sciences runs ISO 11607 packaging validation for medical device manufacturers, end to end. We decide which evidence your device needs, write the protocols and the sample size justification, manage the accredited laboratory that runs the testing, and deliver a submission-ready report that ties every result back to the clause it answers. Your team does not have to learn the standard.

The part that comes back

What a reviewer actually reads.

You can commission every test in the matrix: seal strength, burst, dye penetration, an aging study that comes back clean. A laboratory runs them and hands you reports that pass. Passing the tests was never the hard part.

A reviewer reads for one line of reasoning: the risk in your file, the conditions you tested for, the numbers you accepted, and why each was the right call. A pile of passing reports that nobody has tied into that line is exactly what a reviewer stops on. Tying them together is the real work. We take it off your desk.

What we take on

What lands back on your desk.

We run the whole validation. Packaging is the only thing we do, and we build the section for the questions a reviewer will raise. We work out what the evidence has to prove for your device, and we settle that before anything is built. Any testing goes to an accredited laboratory that fits the method.

What comes back is the packaging section itself, assembled and ready to drop into your submission, every result traced to the clause it answers. You see it before it ships. When a reviewer questions a choice, the reason is already written down, so the answer is one you can give.

The safety net

How we take the risk off you.

Everything here is arranged so the exposure is ours to carry.

  • You are never surprised. Nothing reaches your submission that you have not seen and agreed to first.
  • The price does not move with what we find. Nine gaps or none, the fee is the same, so an assessment has no reason to invent work.
  • A clean bill is a real result. If your packaging is already sound, we write that down plainly and tell you to keep your money.
  • The testing is placed at cost. The laboratory bills you on its own line, and no lab or supplier pays us a commission or rebate.
  • The work is yours to keep. Protocols, data and the finished section stay with you, whatever happens next between us.
  • We stay on the file for two years. If a reviewer questions our work, we help you answer it, with four hours of that support included in a program and one in a gap assessment.
A sheet of polymer film drawn tight over a rectangular form and photographed close in: the lap edge of a second course runs down the left, and fine pull creases converge on a tension point at the right.A sheet of polymer film drawn tight over a rectangular form and photographed close in: the lap edge of a second course runs down the left, and fine pull creases converge on a tension point at the right.

The work, drawn to scale

This is the object your evidence is about.

Chevron-sealed sterile barrier pouch: plan, section through the side seal, and isotropic detail of the seal land, with the validation program annotated. Three keyed figures. FIG 1 is a true-scale plan of a 152 by 254 mm chevron peel pouch at 1.70 px per mm, porous side up, seal stroked as one closed path so the 9.5 mm band is constant width through the apex and both leg junctions. FIG 2 is section 2-2 through the side seal, horizontal scale 20 px per mm, vertical scale exaggerated 40 to 1. FIG 3 is detail A, isotropic at 1.00 px per micron, no vertical exaggeration. PROBITY SCIENCES · STERILE BARRIER SYSTEM · CHEVRON PEEL POUCH 152 × 254 mm · TYVEK 1073B / 48PET-200LDPE ISO 11607-1:2019 · ASTM F88 · F1886 · D4169 · F1980 152 9.5 15.9 20° 254 22 FIG. 1 PLAN VIEW, POROUS SIDE UP. TRUE SCALE,ISOTROPIC, 1.70 px/mm (1:6). NO WALL THICKNESS IS DRAWN. A 5 mm100 µm50 µm FIG. 2 SECTION 2-2. DIAGRAMMATIC, ENLARGED. HORIZONTAL SCALE 20 px/mm.VERTICAL SCALE EXAGGERATED 40:1. THE TWO SCALE BARS BELOW ARE BOTH TRUE. FIG. 3 DETAIL A. ISOTROPIC, 1.00 px/µm. NO VERTICAL EXAGGERATION.THE 30 µm SQUEEZE-OUT FILLET IS 0.6 px WIDE IN FIG. 2 AND IS DRAWN ONLY HERE. 2830 102622 161820 1214202426 10 POROUS WEB · 12 FIBER MAT · 14 SEAL COATING · 16 FILM WEB · 18 PET SKIN · 20 SEALANT · 22 SEAL LAND · 24 SQUEEZE-OUT FILLET · 26 DENSIFIED ZONE · 28 HEADER STRIP · 30 GRIP FLAP
Chevron-sealed sterile barrier pouch: plan, and section through the side seal, recomposed for phone width. Portrait recomposition of the landscape sheet, drawn from the same geometry. Two keyed figures, stacked. FIG. 1 is a true-scale plan of a 152 by 254 mm chevron peel pouch at 1.70 px per mm, porous side up, with the 9.5 mm seal band drawn as one closed path so its width is constant through the apex and both leg junctions, and with cutting plane 2-2 marked across it. FIG. 2 is section 2-2 through the side seal, enlarged: horizontal scale 30 px per mm, vertical scale 1.2 px per micron, an exaggeration of 40 to 1, which is stated on the drawing and carries two true scale bars. It shows the Tyvek 1073B porous web compressed from 178 to 130 microns under the sealing jaw, the amber bond line across the 9.5 mm land, and the 48PET/200LDPE film web with its 50 micron sealant and 12 micron polyester skin. It is broken off 21 mm from the die-cut edge. FIG. 3, detail A of the seal land, is on the landscape sheet only: at 320 by 260 microns its content is finer than a phone can resolve, so it is omitted here rather than printed as a blur. PROBITY SCIENCES · STERILE BARRIER SYSTEM CHEVRON PEEL POUCH 152 × 254 mm · TYVEK 1073B / 48PET-200LDPEISO 11607-1:2019 · ASTM F88 · F1886 · D4169 · F1980 22 152 9.5 15.9 20° 254 2830 FIG. 1 PLAN VIEW, POROUS SIDE UP. TRUE SCALE,ISOTROPIC, 1.70 px/mm. NO WALL THICKNESS IS DRAWN. 262210 2018 16 5 mm100 µm FIG. 2 SECTION 2-2. DIAGRAMMATIC, ENLARGED.HORIZONTAL SCALE 30 px/mm. VERTICAL 1.2 px/µm,AN EXAGGERATION OF 40:1. BOTH SCALE BARS ABOVE ARE TRUE.BROKEN OFF 21 mm FROM THE DIE-CUT EDGE. 10 POROUS WEB · 16 FILM WEB · 18 PET SKIN · 20 SEALANT22 SEAL LAND · 26 DENSIFIED ZONE · 28 HEADER STRIP · 30 GRIP FLAP
The sterile barrier system, drawn to the real construction: Tyvek at 178 micrometers against a 63.5 micrometer film laminate, a 9.5 millimeter seal band, and a 140 degree chevron. That geometry is what a seal strength and integrity case rests on, and it decides which tests the matrix can justify.

Two branches, one calendar

One decision up front sets your schedule.

Stability evidence and performance evidence are separate branches, and no order between them is mandated. Which branches a claim needs is decided and written down before anything ships, because that decision sets the calendar below, and a laboratory queue does not.

Figure 2. One decision, two independent evidence streams, drawn to true elapsed time. A programme chart. On the left, three labelled streams leave one decision, marked in amber, where the test program is defined. On the right they run against a shared, true 90 day axis. Performance evidence, ASTM D4169 distribution simulation, occupies three days and is a short heavy solid bar: an event. Stability evidence, ASTM F1980 accelerated aging, occupies eighty-five days to reach a three year equivalent at 60 degrees Celsius, and is a long ruled measure: a duration. Real-time aging on the same lots runs to 1095 days and leaves the frame. The two held streams stop at the validation report, which the client approves; real time passes through it and continues. One decision. Two independent proofs. ASTM F1980 §1.5 · stability and performance are separate branches 030 6090 days, true scale Test program defined Validation report you approve it Performance ASTM D4169 distribution simulation 3 d testing, then held an event Stability ASTM F1980 accelerated aging 85 d to a 3-year equivalent, 60 °C a duration Real-time aging same lots, started with the accelerated run 1095 d past the submission outlives the submission Solid is testing under way; dotted is evidence held. A combined arm is added only where the risk assessment calls for it. Which arms your claim needs is decided before anything ships, and that decision sets the calendar.
Figure 2. One decision, two independent evidence streams, drawn to true elapsed time. Portrait composition of the same figure. Sterilized samples reach a decision, marked in amber, where the test program is defined. Two independent streams leave it, each drawn against the same true 90 day axis. Performance evidence, ASTM D4169 distribution simulation, occupies three days and is a short heavy bar. Stability evidence, ASTM F1980 accelerated aging, occupies eighty-five days and is a long ruled measure. Real-time aging on the same lots runs to 1095 days and leaves the frame. Both streams converge on the validation report, which the client approves. One decision. Two independent proofs. ASTM F1980 section 1.5 Test program defined We author it. You approve it before anything ships. 030 6090 days, true scale, shared by all three an event, 3 days Performance ASTM D4169 distribution simulation 3 d then the evidence is held a duration, 85 days Stability ASTM F1980 accelerated aging 85 d at 60 °C, ambient 23 °C, Q10 2.0 Combined arm, if risk requires Validation report · you approve it Real time · same lots · 1095 d · outlives the submission
One decision, two independent evidence streams, drawn to true elapsed time: distribution simulation runs three days, accelerated aging eighty-five, and real-time aging out to 1095 days, past the life of the submission. Which arms your claim needs is decided before anything ships, and that decision sets the calendar.

No black box

Every number here is one you can check.

The arithmetic behind the schedule is on the site in full, in a calculator that shows every step. Put in your device and watch the pull points move. If our numbers are going into your submission, you should be able to see where they come from.

Open the accelerated aging calculator

One date worth a calendar note

There is a filing deadline already on the calendar.

One date on this page is worth a note in your calendar: 20 December 2026. After it, a premarket declaration of conformity that points at the un-amended ISO 11607-1:2019, the edition recognized under 14-530, is no longer accepted. If your submission goes in later, the edition your declaration names is worth pinning down now. It is a documentation point: what changes is the edition your paperwork cites, and nothing in the lab needs to move. Have us check which edition your declaration points at, as part of a gap assessment, and clear it well before your filing window.

Check my declaration: $2,500 gap assessmentWhat the 2026 transition actually requires

Start here

The hardest part of your submission, off your plate.

Book a call and we will walk your device and your timeline. Or start with a gap assessment: we read your existing packaging file and hand you one document that says what a reviewer would question and what it takes to close it. Fixed price, and you will know exactly where you stand.

Book a 30-minute callGap assessment: $2,500 fixed